CCSA's Bioinformatics and Data Management departments work together to provide high-quality, cost-efficient solutions for all of our projects. Where possible, CCSA minimizes customer cost by leveraging existing solutions and customizing them for each customer's specific needs. If new development is required, CCSA employs industry-leading off-the-shelf applications as well as caBIG-compliant open-source tools to provide the most appropriate data management solutions that adhere to CCSA, customer, and—if necessary—industry (e.g., HL7 v3) and government standards (e.g., CDISC, caDSR, etc.).
Our Data Managers are integral to any CCSA development effort as the primary end-users of the systems we create. As an essential part of our unit testing and validation efforts, our Data Management personnel provide feedback on requirements, usability, and adherence to applicable regulatory statutes such as 21 CFR PART 11 and HIPAA. CCSA Bioinformatics and Data Management comply with rigorous design, development, testing, validating, and implementing SOPs irrespective of the size of the effort or its intended use (e.g., a complete SAE reporting system or a simple tabular summary report).
In addition to its role in development, our experienced data management team also reviews finalized protocols, mocks up eCRFs, builds and maintains protocol-specific data management systems (DMS) using Oracle Pharmaceutical Applications (OPA), and customizes proprietary databases (built on .net technology) to provide comprehensive solutions for tracking and managing all of our customers' data. Once the complete data management solution has been tested and validated, our Data Managers enter the data themselves and/or train and support study sites on the use of any portion of the system (such as the DMS) to track, collect, clean, analyze, and report on clinical and safety data within and across databases.
While CCSA's bioinformatics and data management organizations use an extensive set of standard technologies, we are nimble enough to conform to customer hardware and software needs, and to build custom solutions using customer standards.
Each client’s unique problem set requires an individual solution. Using our proprietary databases, we can provide comprehensive data on candidate pharmaceutical compounds, analyze and report on current research, and forecast future results based on our extensive archives.
Our databases are constantly updated with the most current information from published literature and clinical trial results using a rigorous review and approval process that relies on our scientists' extensive knowledge of the biomedical field.
The following is a sample of technologies that we employ to build our customers' optimal solution.
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Operating Systems -
- UNIX; Linux; Windows; MAC
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Development Platforms -
- Oracle; .NET; MySQL; J2EE
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Languages -
- PL/SQL; Java; Visual Basic; HTML/XML/SGML(E2B)
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Applications -
- Oracle
- Pharmaceutical Applications (OPA)
- RDBMS
- Portal
- SAS
- Access
- Basic
- Microsoft Access
- Microsoft Office Suite; SUN OpenOffice; Thomson EndNote; Adobe Suites